Job Summary: 

• Establish and nurture relationships with local PV departments of the Exeltis Organization, to ensure compliance with applicable regulations and company procedures.
• Collaborate in the maintenance of the Quality PV system of Exeltis Organization, giving support in the elaboration, update, and implementation of Standard Operating Procedures (SOPs).
• Collaborate in the continuous monitoring of the risk-benefit balance of products owned by Exeltis.
• Ensure proper management and reporting of suspected adverse reactions to Eudravigilance, other Competent Authorities, and partners.
• Participate in internal audits of affiliates and third parties.
• Collaborate during inspections of Exeltis PV system.
• Ensure proper elaboration, review, and submission of aggregate safety reports, such as PSURs, DSURs, and RMPs.
• Collaborate in the coordination of responses to Health Authorities.
• Collaborate in the Medical Literature Monitoring Process and the review of webpages and media relevant to PV activities.
• Contribute to generating PV awareness across the Organization, by providing PV training for Exeltis employees and participating in the continuous training of other PV colleagues in the department.
• Collaborate in the elaboration, review, and implementation of PV contracts and agreements with different stakeholders.
• Ensure adequate interface and communication with other departments performing activities impacting Exeltis PV system
• Keep PV files safe, accurate, updated, and complete, in compliance with internal standards and applicable regulations.

Skills on Resume:

• Relationship Management (Soft Skills)
• Regulatory Compliance (Hard Skills)
• SOP Development (Hard Skills)
• Risk Monitoring (Hard Skills)
• Adverse Reporting (Hard Skills)
• Auditing (Hard Skills)
• Safety Reports (Hard Skills)
• PV Training (Soft Skills)

Job Summary: 

• Coordinate activities to address safety issues for global and domestic clinical studies, and direct PVG team efforts for any safety review committee (SRC) and Drug Safety Monitoring Board (DSMB) activities
• Process SAEs including triaging, entering into the SAE database, writing narratives, and preparing for regulatory submission
• Mentor PVG staff in processing SAEs
• Ensure the integrity of SAE data, including performing QC of cases entered by PVG staff
• Serve as PVG representative on study teams
• Manage clinical study project set-up/close-out, regulatory reporting
• Represent PVG in Nant internal and external team meetings
• Coordinate coding and reconciliation processes
• Resolve complex problems through in-depth evaluation of various factors and collaboration with stakeholders
• Maintain up-to-date knowledge of required therapeutic areas and regulatory requirements for SAE processing
• Possibly assist in the generation and writing of DSURs and other periodic reporting

Skills on Resume:

• Safety Issue Coordination (Soft Skills)
• SAE Processing (Hard Skills)
• Staff Mentoring (Soft Skills)
• Data Integrity (Hard Skills)
• Study Team Representation (Soft Skills)
• Project Management (Hard Skills)
• Problem Resolution (Soft Skills)
• Regulatory Knowledge (Hard Skills) 

Job Summary: 

• Monitors the submission work list in the safety database for cases requiring submission or distribution to regulatory authorities and all relevant reporting destinations by case priority and report due date
• Performs ICSR submissions (in E2B form via Gateway/EVWEB and CIOMs/MedWatch) and monitors E2B submission for transmit status
• Initiates and executes backup procedures if necessary to address electronic submission failures
• Performs E2B submission validation check and manages rejected E2B transmissions via Gateway and ensures successful re-transmission as appropriate
• Works collaboratively with Global Case Management in workflow monitoring and coordinates database action items to ensure timely submission and completion
• Performs reconciliation activities including but not limited to receipt of all AEs from Business Partners
• Partners with Global Quality Systems to ensure reconciliation of Product Complaint Investigation Reports
• Partners with other functional teams (i.e. quality, compliance, analytics) for the generation and verification of monthly reconciliation metrics
• Works collaboratively with the R&D Quality & Compliance team to evaluate the performance, identify bottlenecks, minimize regulatory risks, and recognize patterns of inefficiencies in current operational processes
• Contributes content and/or review to new or revised standard operating procedures, work instructions, and training material when new and/or updated processes are introduced
• Participates in the review of regulatory intelligence information related to submission requirements

Skills on Resume:

• Submission Monitoring (Hard Skills)
• ICSR Submissions (Hard Skills)
• Backup Procedures (Hard Skills)
• E2B Validation (Hard Skills)
• Workflow Coordination (Soft Skills)
• Reconciliation Activities (Hard Skills)
• Process Improvement (Soft Skills)
• Regulatory Review (Hard Skills)

Job Summary: 

• Work with Safety System Teams to provide updates to reporting rules (for new business partners and vendors)
• Involvement in User Acceptance Testing for Safety database upgrades.
• Involvement in CAPA Management.
• Involvement in peer, business partner/vendor training.
• Involvement in meeting with cross functional groups in global case management/submissions and providing inputs for process improvements.
• Act as Submissions Subject Matter Expert for assigned products.
• Works collaboratively with Safety Data Exchange Agreement review and provide inputs related to submission and reconciliation requirements based on available regulatory intelligence.
• Supports audits and inspections
• Interacts with internal and external stakeholders regularly
• Ensure compliance with corporate and departmental standard operating procedures
• As an individual contributor, may serve as a project manager for functional projects or workflows

Skills on Resume:

• Reporting Rules Updates (Hard Skills)
• User Testing (Hard Skills)
• CAPA Management (Hard Skills)
• Training (Soft Skills)
• Process Improvement (Soft Skills)
• Submissions Expertise (Hard Skills)
• Safety Agreement Review (Hard Skills)
• Audit Support (Hard Skills) 

Job Summary: 

• Ensures that all safety reports received from any source for Cytokinetics’ investigational products are processed in the safety database and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, Work Instructions, departmental procedures, and business partner agreements
• Ensures consistency in the evaluation and assessment of each incoming case report and source document for completeness, accuracy, and legibility
• Assists with quality review of cases to ensure the accuracy, integrity, and completeness of information entered into the safety database, including appropriateness and accuracy of MedDRA and WHO-DD coding and generation of high-quality medically/scientifically sound individual case safety reports (ICSR)
• Determines necessary follow-up for missing, discrepant, or additional information/source documentation for each case using medical, product, and regulatory knowledge to complete ICSRs
• Coordinates and monitors the distribution and submission of expedited and non-expedited individual case safety reports to regulatory authorities, business partner companies, CROs, and investigators to ensure compliance with regulatory and company timelines
• Assists with the mentoring, training, and support for departmental team members for high quality and consistent execution of daily activities in the Drug Safety Department
• Participates in assigned study activities including participation in Study Operation Team meetings and preparation of study start-up activities (e.g., development of study-specific Safety Management Plans, training of internal/external project-team members in safety-reporting processes, development of safety report forms, safety data reconciliation, site initiation training activities)
• Assists with the preparation of periodic and annual safety reports
• Assists with the preparation of safety data presentations for departmental meetings (e.g., Drug Safety Committee Meetings)
• Assists with maintenance of drug safety database including required software updates and testing in validation required for each new Cytokinetics study
• Assists with departmental activities as assigned (e.g., monitoring Drug Safety Inbox, preparation of monthly listings for distribution (e.g., DMC).

Skills on Resume:

• Safety Report Processing (Hard Skills)
• Case Evaluation (Hard Skills)
• Quality Review (Hard Skills)
• Follow-up Management (Hard Skills)
• Report Distribution (Hard Skills)
• Mentoring and Training (Soft Skills)
• Study Support (Soft Skills)
• Database Maintenance (Hard Skills)